FDA.reportPublic FDA data

Esomeprazole Magnesium

Product NDC
71335-2018
11-digit product format
713352018
Labeler code
71335
Product ID
71335-2018_d95a3df7-b940-4a73-8238-3608e58ca70b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Esomeprazole Magnesium
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA211977
Marketing category
ANDA
Marketing start
2020-06-02
Substance
ESOMEPRAZOLE MAGNESIUM
Active strength
20 mg/1
Pharmacologic classes
Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Esomeprazole Magnesium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ESOMEPRAZOLE MAGNESIUM20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR6DXU4WAY9
Rxcui606726

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d7006a36-e68d-42e2-8cd3-d725cb2e47b1Product name620251027
d71865e8-5c35-4d76-8ecd-a7adda982240Product name920180628
d71865e8-5c35-4d76-8ecd-a7adda982240Product name820171212
094c6751-235c-4d12-acee-2baf94f676f4Product name120151116
ce67e27d-1d21-5465-4409-b0662dd99d4dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-2018-1Esomeprazole Magnesium30 in 1 BOTTLECAPSULE, DELAYED RELEASE30103
71335-2018-2Esomeprazole Magnesium10 in 1 BOTTLECAPSULE, DELAYED RELEASE10103
71335-2018-3Esomeprazole Magnesium60 in 1 BOTTLECAPSULE, DELAYED RELEASE60103
71335-2018-4Esomeprazole Magnesium90 in 1 BOTTLECAPSULE, DELAYED RELEASE90103
71335-2018-5Esomeprazole Magnesium42 in 1 BOTTLECAPSULE, DELAYED RELEASE42103
71335-2018-6Esomeprazole Magnesium120 in 1 BOTTLECAPSULE, DELAYED RELEASE120103
71335-2018-7Esomeprazole Magnesium180 in 1 BOTTLECAPSULE, DELAYED RELEASE180103
71335-2018-8Esomeprazole Magnesium20 in 1 BOTTLECAPSULE, DELAYED RELEASE20103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2018-3EA - Each71335-201838d05f8d-ccec-441e-8260-d0b7a56be00312025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2018ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 8 package rows20240824_7778bf7c-52f7-44b3-ac2c-e5a25f6967b7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSN7778bf7c-52f7-44b3-ac2c-e5a25f6967b7103
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCD7778bf7c-52f7-44b3-ac2c-e5a25f6967b7103
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSY7778bf7c-52f7-44b3-ac2c-e5a25f6967b7103
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSY7778bf7c-52f7-44b3-ac2c-e5a25f6967b7103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-2018-17133520180130 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2018-1) 2022-02-100000-00-00NoNoCurrent
71335-2018-27133520180210 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2018-2) 2022-02-100000-00-00NoNoCurrent
71335-2018-37133520180360 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2018-3) 2022-02-100000-00-00NoNoCurrent
71335-2018-47133520180490 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2018-4) 2022-02-100000-00-00NoNoCurrent
71335-2018-57133520180542 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2018-5) 2022-02-100000-00-00NoNoCurrent
71335-2018-671335201806120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2018-6) 2022-02-100000-00-00NoNoCurrent
71335-2018-771335201807180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2018-7) 2022-02-100000-00-00NoNoCurrent
71335-2018-87133520180820 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2018-8) 2022-02-100000-00-00NoNoCurrent